Warning Letter of the Week: "trial analysis" edition Hello friend AMERICAN WORKERS LOOKING FOR JOBS, In the article you read this time with the title Warning Letter of the Week: "trial analysis" edition, we have prepared this article well for you to read and take information in it. hopefully the contents of the post Article bank, Article contracting, Article health, Article lecturer, Article manufacturing, Article marketing, Article property, Article public, Article teachers, Article telecommunications,what we write can you understand. okay, happy reading.

Judul : Warning Letter of the Week: "trial analysis" edition
link : Warning Letter of the Week: "trial analysis" edition

Warning Letter of the Week: "trial analysis" edition

A letter from the Center for Drug Evaluation and Research to the President and CEO of Yuki Gosei Kogyo Co., Ltd. of Tokyo: 

1.      Failure to maintain complete data derived from all laboratory tests conducted to ensure your API complies with established specifications and standards. Your firm does not ensure that complete data from testing of your API are included in the official batch record and reviewed by your quality unit. For example, you reported passing results for related substances testing of [redacted] lot #[redacted] analyzed starting at [redacted] on July 28, 2015. However, our investigator found unreported analyses including out-of-specification (OOS) results for the same lot acquired earlier on the same date, and on the next day as the reported results. You failed to include this data to be reviewed by your quality unit prior to the release of the lot. Our investigator documented the same pattern with other products not intended for the U.S. market.

In your response, you explained that this “trial analysis” was performed on the sample solution for conditioning the high-performance liquid chromatography (HPLC) column. However, your explanation did not address why the “trial analysis” was performed using a sample solution instead of a standard solution, or why you ran this extra analysis in addition to the system suitability test, which verifies that a chromatographic system is adequate as set forth in USP 621.

You also acknowledged that a retrospective review conducted after the inspection found additional instances of unreported electronic data in original batch records. Your review only assessed laboratory data and did not assess all parts of your facility’s operation where CGMP information is generated and maintained. In addition, you failed to provide details of your review criteria and methodology. 

These FDA inspectors, picky-picky! 

Such is the article Warning Letter of the Week: "trial analysis" edition

That's an article Warning Letter of the Week: "trial analysis" edition this time, hopefully it can benefit you all. well, see you in other article postings.

You are now reading the article Warning Letter of the Week: "trial analysis" edition with the link address https://americanworkerslooking.blogspot.com/2018/08/warning-letter-of-week-trial-analysis.html

Tweet

Subscribe to receive free email updates: